FDA-Device2019-03-27Class II
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.
AAP Implantate Ag
Hazard
There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.
Sold states
Worldwide Distribution - US Nationwide in the state of Texas and country of Germany
Affected count
25 units
Manufactured in
Lorenzweg 5, N/A, Berlin, N/A, Germany
Products
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1019-2019Don't want to check this manually?
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